Bovie Medical Receives 510K Clearance for Its Cool-Coag™ Generator and Open Handpiece

Tuesday, Mar 28, 2017

Bovie Medical announced today that it has received 510K clearance from the FDA for a new J-Plasma® generator and handpiece that incorporate Cool-Coag™ technology.

Cool-Coag™ is a new technology that combines the unique benefits of J-Plasma®, namely increased precision with minimal thermal spread, with standard monopolar coagulation and helium spray coagulation capabilities, all in one handpiece. This allows the surgeon to benefit from using a single device that offers the greater control of tissue effect that J-Plasma® delivers, while being able to switch to a monopolar or helium spray coagulation mode with just the push of a button.

“The development of Bovie’s Cool-Coag™ technology is a direct result of feedback from surgeons who have used our J-Plasma® product for procedures that require greater coagulation capability, specifically in the areas of gynecologic oncology and surgical oncology,” said Robert L. Gershon, Chief Executive Officer. “The unique flexibility of Cool-Coag™ enables the surgeon to use J-Plasma® to perform the most delicate procedures, where precision and low risk of injury to surrounding tissue are paramount and also have the full power of monopolar coagulation to control, pinpoint and diffuse bleeding as needed.”

“This new Cool-Coag™ technology has the potential to increase usage of the J-Plasma® device in many of our most complex cancer procedures. It combines J-Plasma®’s ability to be used close to vital structures with minimal collateral damage and standard full monopolar coagulation capability, all in one hand-held instrument. Cool-Coag™ may also expand the use of J-Plasma® in additional procedures and specialties,” said Dr. Dennis Chi, head of the Ovarian Cancer Surgery at Memorial Sloan Kettering Cancer Center in New York City.

“We are pleased with our ability to continue to provide innovation that meets the needs of surgeons and are confident in the substantial growth opportunity for J-Plasma® as we continue to penetrate the market,” Mr. Gershon noted.